Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-04-23

Brief Summary

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This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 168 eligible patients with severe novel coronavirus pneumonia.

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Detailed Description

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Conditions

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COVID-19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Jaktinib 75mg BID

Group Type EXPERIMENTAL

Jaktinib hydrochloride tablets

Intervention Type DRUG

75mg of Jaktinib administered orally Twice daily(BID) with best available treatment.

Jaktinib 100mg BID

Group Type EXPERIMENTAL

Jaktinib hydrochloride tablets

Intervention Type DRUG

100mg of Jaktinib administered orally Twice daily(BID) with best available treatment.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo (given as two placebo tablets) administered orally BID with best available treatment.

Interventions

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Jaktinib hydrochloride tablets

75mg of Jaktinib administered orally Twice daily(BID) with best available treatment.

Intervention Type DRUG

Jaktinib hydrochloride tablets

100mg of Jaktinib administered orally Twice daily(BID) with best available treatment.

Intervention Type DRUG

Placebo

Placebo (given as two placebo tablets) administered orally BID with best available treatment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age, male or female;
* The Participants was diagnosed with novel coronavirus pneumonia;
* It meets the heavy-duty standards of the new coronavirus pneumonia diagnosis and treatment protocol (version 9).
* Participants who voluntarily sign informed consent.
* The National Institute of Allergy and Infectious Diseases Sequential Scale (NIAID-0S) score is 5 or 6;

Exclusion Criteria

* Participants who cannot take orally, or are suspected to be allergic to Jaktinib, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption;
* Participants who have received the following treatments within the specified time window before randomization:

1. Participants have received Janus kinase (JAK) inhibitor, interleukin 6 (IL-6) inhibitor, IL-1 inhibitor, tumor necrosis factor (TNF) inhibitor, T cell or B cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid;
2. Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half lives at random;
* Immune deficiency;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No